Note: The revision of this Import Alert (IA) dated 10/25/2022 updates the product description and the product codes. Changes to the import alert are bracketed by asterisks (***). During the early 2000s there were four multi-state Salmonellosis outbreaks traced back to Mexican cantaloupes. The pathogen identified in three of the outbreaks was Salmonella Poona and in the other outbreak Salmonella Anatum. These outbreaks led to multiple hospitalizations and two deaths. Additionally, in the early 2000s, FDA collected and analyzed samples of Mexican cantaloupes for Salmonella analysis, finding multiple violations. In 2021, the Division of Import Operations (DIO) in conjunction with the Center for Food Safety & Applied Nutrition (CFSAN) analyzed FDA sampling data from 2012-2020 for products subject to DWPE under this Import Alert (IA). It was determined that there is still a high rate of contamination and Salmonella remains a concern for products that fall under the scope of this IA. Salmonella lives in the intestinal tracts of humans and other animals. Thus, the organism may be transmitted to humans by eating foods contaminated with fecal material from humans or other animals. Random events in nature, such as animal defecating on a cantaloupe growing in the field, may cause the product to become contaminated with Salmonella and, subsequently, result in illness. However, FDA believes that it is extremely unlikely that there would be repeated multi-state outbreaks of salmonellosis, attributable to a specific species of Salmonella with indistinguishable pulse field gel electrophoresis (PFGE) patterns if contamination was derived from random events in nature. Moreover, in the outbreaks of the early 2000s, the illnesses were spread over a wide geographical area in the U.S., as well as in Canada, and occurred over a 6-week period. These facts suggest that more than one shipment was the cause and make it extremely unlikely that a random natural event or events caused the contamination. FDA believes that the source of Salmonella contamination is most likely attributable to a broader source of contamination. Sources of contamination may include irrigation of fields with water contaminated with sewage, processing ("cleaning and cooling") produce with Salmonella contaminated water, and/or poor hygienic practices of workers that harvest and process the produce, pests in packing facilities, and lack of adequate cleaning and sanitizing of equipment that comes in contact with the product. Inspectional findings at a number of cantaloupe growing areas and packing sheds in Mexico revealed that Mexican cantaloupe are indeed manufactured, processed, or packed under insanitary conditions. Further, these inspections underscore the lack of an overall environmental sanitation program, as well as apparent lack of regulatory authority in Mexican law to address the insanitary conditions that FDA believes lead to Salmonella contamination. In addition, practices that result in product from different states being commingled means that any shipment of cantaloupe may contain fruit from states that have been the source of contaminated cantaloupe. FDA believes that cantaloupe imported from Mexico appear to be adulterated under Section 801(a)(3) of the Act because they appear (1) to contain Salmonella, an added poisonous or deleterious substance that may render food injurious to health within the meaning of section 402(a)(1) of the Act and (2) to have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health within the meaning of Section 402(a)(4) of the Act. In addition, the cantaloupe violate section 801 (a)(1) of the Act in that they appear to have been manufactured, processed, or packed under insanitary conditions. This alert covers both whole cantaloupe and sliced, chopped, or diced cantaloupe. The processing associated with producing fresh versus intact produce increases the opportunity for contamination and the chance of cross contamination over an even larger volume of product. Furthermore, processes such as cutting, dicing, and slicing, increase the surface area available for contamination and growth of microorganisms. Nutrients to support microbial growth (i.e., from plant juices and exposed flesh) are also more available. Concerns about pathogens are further amplified when the characteristics of the particular fruit or vegetable (e.g. pH) can support their growth. This is the case with many vegetables, certain soft fruit, and melons, including cantaloupe.
***Cantaloupes, Hami melons, Galia melons, fresh, frozen and processed (This includes fresh cantaloupe, hami melon and galia melon sliced/chopped for salad bars.)***
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain Salmonella, a poisonous and deleterious substance which may render it injurious to health. [Adulteration, Section 402(a)(1)] OASIS charge code: SALMONELLA and The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. [Adulteration, Section 402(a)(4) OASIS charge code: INSANITARY and The article is subject to refusal of admission pursuant to section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions. OASIS charge code: MFR INSAN
Divisions may detain, without physical examination, all raw and raw fresh refrigerated cantaloupes, frozen, and processed cantaloupe, including fresh cantaloupe sliced/chopped for salad bars offered for importation from the country of Mexico except from those firms listed on the Green List of this import alert. Firms on the Yellow List should be detained using the SALMONELLA charge code. Firms subject to this Import Alert and not listed on the Yellow or Green List should be detained using charge codes SALMONELLA, INSANITARY, and MFR INSAN. NOTE: Since the article is subject to Refusal of Admission per Section 801(a)(1) of the Act, FDA considers submission of analytical results indicating the absence of Salmonella to be insufficient to overcome the appearance of the product having been prepared, packed, or held under insanitary conditions. In addition, the appearance of a violation per Section 801 (a)(1) of the Act precludes reconditioning under Section 801(b) of the Act. On October 26, 2005, the Food and Drug Administration (FDA) and the Mexican Servicio Nacional de Sanidad Inocuidad y Calidad Agroalimentaria (SENASICA) signed a Memorandum of Understanding dealing with Mexican cantaloupe to be imported to the United States. Under the terms of the MOU, SENASICA would identify cantaloupe firms as being in compliance with FDA's Produce Safety Rule (PSR (21 CFR 112). The PSR will be used by SENASICA to determine if a firm is growing and harvesting cantaloupes under sanitary conditions and can be deemed a Category 3 firm as described in the MOU. Category 3 firms will be listed in the yellow list for this import alert. Request for addition to Yellow List: All requests for addition of a firm to the yellow list of this import alert should be referred by DIO to CFSAN, Office of Compliance, Division of Enforcement, Food Adulteration Assessment Branch for evaluation. In order to assess the adequacy of the firm's agricultural, processing, and transportation practices, FDA personnel should review information submitted describing the firm's practices in the following areas: * Water quality in irrigation, packing, and cooling; * Manure use and biosolids, animal management; * Worker health and hygiene; * Sanitary facilities in field and packing house, disposal of sewage and silage; * Maintenance program for cleaning, sanitizing equipment; * Field and packing facility sanitation; * Transportation; * If applicable, steps taken to identify and correct insanitary conditions which are indicated by positive analytical results for Salmonella in the firm's product, or as a result of an epidemiological traceback investigation. Further details and examples of the types of information that can be submitted can be found in FDA's Good Agricultural Practices (Oct 1998). After reviewing these submissions, FDA, either solely or in conjunction with the relevant Mexican regulatory authority, may conduct a limited number of on-site inspections of the growing/processing areas to audit the validity of the information submitted to FDA. FDA intends to give priority in scheduling these inspections to firms or growers who provide certification from an independent institution or third party that has expertise in agricultural and transportation processes. Firms Subject to Yellow List: The Category 3 firms named in the yellow list will be required to make five entries and show laboratory results that are negative for Salmonella as described in the MOU. Once they have five shipments shown to be free of Salmonella, the firm should submit a request to DIO to have the firms moved from the yellow list to the green list of Import Alert 22-01, which exempt the firms from DWPE. Request for Addition to Green List: All requests for addition of a firm to the green list of this import alert may be reviewed by DIO. Concurrence from CFSAN, Office of Compliance is not required. Removal from Detention without Physical Examination: In order to remove a firm's product from detention without physical examination, information should be provided to FDA to adequately demonstrate that the manufacturer has resolved the conditions that gave rise to the appearance of the violation. The purpose of this is so that the Agency will have confidence that future shipments/entries will be in compliance with the Federal Food Drug and Cosmetic Act (FD&C Act). For further guidance on removal from detention without physical examination, refer to FDA's Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention without Physical Examination (DWPE)." If a firm and/or a representative thereof would like to petition for addition to the yellow list or removal from detention without physical examination under this Import Alert (addition to Green List), all relevant information supporting the request should be forwarded to the following address: Food and Drug Administration Division of Import Operations 12420 Parklawn Drive, ELEM-3109 Rockville, MD 20857 Or via email to: Importalerts2@fda.hhs.gov Questions or issues involving import operations should be addressed to OII Division of Import Operations (DIO) at (301) 796-0356 or Imports@fda.hhs.gov. Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to FDAPRIVATELABIMPORTALERTS@fda.hhs.gov Questions or issues with regard to human food on policy, sample collection recommendations, or any additional questions not directly related to a detained entry, should be addressed to the Human Foods Program Imports Enforcement Branch at HFP-OCE-Imports@fda.hhs.gov
This alert authorizes Detention Without Physical Examination (DWPE) for products matching this alert. Reason: Note: The revision of this Import Alert (IA) dated 10/25/2022 updates the product description and the product codes. Changes to the import alert are bracketed by asterisks (***). During the early 2000s there were four multi-state Salmonellosis outbreaks traced back to Mexican cantaloupes. The pathogen identified in three of the outbreaks was Salmonella Poona and in the other outbreak Salmonella Anatum. These outbreaks led to multiple hospitalizations and two deaths. Additionally, in the early 2000s, FDA collected and analyzed samples of Mexican cantaloupes for Salmonella analysis, finding multiple violations. In 2021, the Division of Import Operations (DIO) in conjunction with the Center for Food Safety & Applied Nutrition (CFSAN) analyzed FDA sampling data from 2012-2020 for products subject to DWPE under this Import Alert (IA). It was determined that there is still a high rate of contamination and Salmonella remains a concern for products that fall under the scope of this IA. Salmonella lives in the intestinal tracts of humans and other animals. Thus, the organism may be transmitted to humans by eating foods contaminated with fecal material from humans or other animals. Random events in nature, such as animal defecating on a cantaloupe growing in the field, may cause the product to become contaminated with Salmonella and, subsequently, result in illness. However, FDA believes that it is extremely unlikely that there would be repeated multi-state outbreaks of salmonellosis, attributable to a specific species of Salmonella with indistinguishable pulse field gel electrophoresis (PFGE) patterns if contamination was derived from random events in nature. Moreover, in the outbreaks of the early 2000s, the illnesses were spread over a wide geographical area in the U.S., as well as in Canada, and occurred over a 6-week period. These facts suggest that more than one shipment was the cause and make it extremely unlikely that a random natural event or events caused the contamination. FDA believes that the source of Salmonella contamination is most likely attributable to a broader source of contamination. Sources of contamination may include irrigation of fields with water contaminated with sewage, processing ("cleaning and cooling") produce with Salmonella contaminated water, and/or poor hygienic practices of workers that harvest and process the produce, pests in packing facilities, and lack of adequate cleaning and sanitizing of equipment that comes in contact with the product. Inspectional findings at a number of cantaloupe growing areas and packing sheds in Mexico revealed that Mexican cantaloupe are indeed manufactured, processed, or packed under insanitary conditions. Further, these inspections underscore the lack of an overall environmental sanitation program, as well as apparent lack of regulatory authority in Mexican law to address the insanitary conditions that FDA believes lead to Salmonella contamination. In addition, practices that result in product from different states being commingled means that any shipment of cantaloupe may contain fruit from states that have been the source of contaminated cantaloupe. FDA believes that cantaloupe imported from Mexico appear to be adulterated under Section 801(a)(3) of the Act because they appear (1) to contain Salmonella, an added poisonous or deleterious substance that may render food injurious to health within the meaning of section 402(a)(1) of the Act and (2) to have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health within the meaning of Section 402(a)(4) of the Act. In addition, the cantaloupe violate section 801 (a)(1) of the Act in that they appear to have been manufactured, processed, or packed under insanitary conditions. This alert covers both whole cantaloupe and sliced, chopped, or diced cantaloupe. The processing associated with producing fresh versus intact produce increases the opportunity for contamination and the chance of cross contamination over an even larger volume of product. Furthermore, processes such as cutting, dicing, and slicing, increase the surface area available for contamination and growth of microorganisms. Nutrients to support microbial growth (i.e., from plant juices and exposed flesh) are also more available. Concerns about pathogens are further amplified when the characteristics of the particular fruit or vegetable (e.g. pH) can support their growth. This is the case with many vegetables, certain soft fruit, and melons, including cantaloupe.
This alert covers products from: MEXICO.
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